Findings from a newly released study by KMR Group found that the time it takes to get a site contract approved is five to six weeks on average. The time has remained steady from 2006 to 2009. The study, which included major pharmaceutical companies, focused on understanding how well companies were able to get sites up and running with respect to the contracting process. The study examined contracts during the 2006 through 2009 time period.
To the extent companies can reduce the contracting process, they can in turn reduce all around recruitment cycle time, the key component and most time consuming portion of a clinical trial. Current recruitment times average about 50 weeks for all phases, patient trials. Less start up time ultimately increases on market patent life and optimizes use of critical resources.
In addition to the overall contract time, the study found timing differences across geography, therapy and the type of site being engaged. For example, significant differences in performance were found between institutional versus independent sites. Cycle times at institutional sites are longer and have a larger variance than those from independent sites. Also, institutional sites have significantly longer cycle times in the Northeast and Midwest.
With respect to therapy areas, cycle times for contracts associated with Oncology trials are more than 2 times as long as those associated with Lipid & Metabolic trials. The study also found that there is a considerable amount of variance between pharma companies, with some showing consistently better performance, demonstrating that best practices can lead to improved performance, said the company.